USP Defers Implementation of Elemental Impurities Provisions - USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new

ADVERTISEMENT

USP Defers Implementation of Elemental Impurities Provisions
USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.


In a compendial notice issued on May 24, 2013, the Chair of the USP Council of Experts, in consultation with the Executive Committee of the Council of Experts, has deferred proposed 5.60.30 Elemental Impurities in General Notices. This proposed revision suggested a May 1, 2014 date linking General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures to drug product monographs in the United States Pharmacopeia (USP).  As such, section 5.60.30 will not be included in the General Notices that will be published in USP 37–NF 32, and therefore there is no requirement for any drug product in the USPNF to comply with <232> and <233> at this time, said USP in the notice. The proposed omission of General Chapter <231> Heavy Metals also has been deferred. 

USP said these deferrals will allow USP to work closely with ICH Q3D to align its activities with the implementation of General Chapters <232> and <233>. The deferral also allows USP to work with those affected by the new elemental impurity standards.  In this regard, USP plans to form an Advisory Group on the Implementation of General Chapters <232> and <233>.

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Contract Research and Manufacturing Organization Paragon Bioservices Raises $13 Million
October 28, 2014
Yale and Gilead Extend Sequencing Initiative
October 28, 2014
Author Guidelines

Click here